1. Field of the Invention
The present invention relates to urinary incontinence devices. In particular, the present invention relates to devices for managing female urinary incontinence.
2. Description of Related Art
Urinary incontinence is believed to affect 15% to 30% of non-institutionalized people over the age of 60, and over 50% of the people in convalescent and nursing homes. Treatment for urinary incontinence generally falls into the following categories: (1) management devices, which either restrict the flow of urine, or simply redirect and retain the urine; (2) behavioral treatment, which involves bladder re-training by voiding on a timed schedule or the performance of exercises to strengthen pelvic muscles; (3) pharmacological treatment, which involves the long-term use of drugs; and (4) surgical treatment, which involves the performance of major surgery while the patient is under anesthesia. Although each of these categories of treatment offer some measure of relief, each has significant side effects. The present invention relates to the management of female urinary incontinence.
There are many female urinary incontinence management and control devices on the market at this time, ranging from the most intrusive: urinary tract catheters; to the least intrusive: diapers. Neither of these devices, nor anything in between, offer the safe, comfortable, and non-traumatic control or management of female urinary incontinence. Although urinary tract catheters, such as Foley catheters, are often necessary, their intrusive nature often leads to urinary tract infections. In addition, the insertion and extraction of Foley catheters are quite traumatic for the patient. On the other hand, although diapers are quick and easy to use, and are non-intrusive, they often lead to skin breakdown, and are virtually useless when it is necessary to maintain an accurate measure of a patient""s fluid intake and output.
The following U.S. patents represent attempts to manage or control female urinary incontinence: U.S. Pat. No. 3,554,184 to Habib; U.S. Pat. No. 3,661,155 to Lindan; U.S. Pat. No. 3,705,575 to Edwards; U.S. Pat. No. 4,139,006 to Corey; U.S. Pat. No. 4,875,898 to Eakin; U.S. Pat. No. 4,889,532 to Metz et al.; U.S. Pat. No. 5,049,144 to Payton; U.S. Pat. No. 5,263,947 to Kay; U.S. Pat. No. 5,792,042 to Cohen et al.; U.S. Pat. No. 5,887,593 to Levius; U.S. Pat. No. 5,895,349 to Tihon; U.S. Pat. No. 5,908,379 to Schaefer et al.; and 5,976,068 to Hakky et al. All of these devices, with the exception of U.S. Pat. No. 5,263,947 are invasive devices. Not only are invasive devices uncomfortable for the patient, they can cause significant trauma to the patient during insertion and removal. In addition, the risk of urinary tract infection is typically higher with invasive devices.
There is a need for a female urinary incontinence management device that is non-intrusive and that has replaceable components.
Therefore, it is an object of the present invention to provide a female urinary incontinence management device that is non-intrusive and that has replaceable components.
The above objects are achieved by providing a female urinary incontinence management device having a base member that adhesively attaches to the patient, and a bag member that is sealingly and releasably attached to the base member. The base member is generally triangular having a top portion that, when attached to the patient, extends across and above the symphysis pubis, side portions that extend down along the groin area, and a short bottom portion that extends across the perineal area. The base member includes an upraised ridge portion into which is integrated a xe2x80x9cfemalexe2x80x9d part of a means for sealing the base member to the bag member. The bag member includes a similar upraised ridge portion into which is integrated a xe2x80x9cmalexe2x80x9d part of the means for sealing the base member to the bag member. The bag member may be releasably and sealingly coupled to the base member by interlockingly squeezing the xe2x80x9cmalexe2x80x9d and xe2x80x9cfemalexe2x80x9d parts together. In this manner, the bag member may be interchanged several times without having to remove the base member from the patient.
The present invention has significant advantages, including: (1) it prevents skin breakdown, because urine is prevented from remaining in contact with the skin; (2) it prevents urinary tract infections, because the device is non-intrusive; (3) it improves patient comfort, because the device does not excessively compress the urethra or restrict urine flow; (4) it allows accurate measuring of output of fluids without internal catheterization; and (5) it reduces the number linen changes, resulting in savings in time, cost, and labor.
The above objects and advantages, as well as others, will be evident from the following detailed description of the present invention.